BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BY THE COMPLAINANT

    MDR report key: 3800411 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00071
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    April 1, 2014
    Manufacturer
    COOK BIOTECH, INCORPORATED
    Product Code
    PAG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT NAME NOT KNOWN DUE TO PRODUCT UNSPECIFIED BY THE COMPLAINANT. PRODUCT COMMON NAME NOT KNOWN DUE TO PRODUCT UNSPECIFIED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT; PRODUCT EXPIRE DATE UNKNOWN AS LOT NUMBER NOT KNOWN; PRODUCT CATALOG NUMBER UNKNOWN AS PRODUCT UNKNOWN. 510(K) UNKNOWN; PRODUCT UNSPECIFIED. PRODUCT MANUFACTURE DATE UNKNOWN AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. CONCLUSION - ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. THE PRODUCT CODE LISTED IS NOT NECESSARILY THE PRODUCT CODE ASSIGNED TO THE DEVICE 510(K), BUT RATHER THE PRODUCT CODE THAT SEEMS THE MOST APPROPRIATE BASED ON THE SURGICAL PROCEDURE IN WHICH THE PRODUCT WAS IMPLANTED. INVESTIGATION INTO THIS CLAIM INCLUDED A REVIEW OF THE CLAIM ALLEGATION AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE UNSPECIFIED STRATASIS GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH THE ADVANTAGE FIT SLING SYSTEM AND AN UNSPECIFIED SURGISIS PRODUCT ON (B)(6) 2010, AT (B)(6) HOSPITAL IN (B)(6) BY DR. (B)(6) TO TREAT HER STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFORMATION OF THE ALLEGED INJURY. SPECIFIC INFORMATION REGARDING WHETHER INTERVENTION WAS PERFORMED. SPECIFIC INFORMATION REGARDING WHY INTERVENTION WAS PERFORMED OR WHAT TYPE/TO WHAT EXTENT INTERVENTION WAS PERFORMED. SPECIFIC CORRELATION BETWEEN DEVICE PERFORMANCE AND ALLEGED INJURY. CURRENT PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200376 UNSPECIFIED BY THE COMPLAINANT UNKNOWN PAG COOK BIOTECH, INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability ADVANTAGE FIT SLING SYSTEM